Device recall: Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care p

FDA enforcement event 72992 · Class II · initiated 7 Jan 2016 · status Terminated · terminated 3 May 2017

DeviceVoluntary: Firm initiated100 product recordsFajardo, PR

Customed, Inc (Fajardo, PR) initiated this device recall on 7 Jan 2016; FDA lists 100 product records under event 72992, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 3 May 2017. Initiation: voluntary: firm initiated. Customed, Inc has 4 enforcement events on this register, with a median of 179 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Customed, Inc, Fajardo, PR.

Reason for recall

"Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile."

Distribution

"Distributed only in Puerto Rico."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1397-2016	Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	540	Class II	Terminated	20 Apr 2016
Z-1398-2016	Catalog Number: 900010 SUTURE REMOVAL KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	9000	Class II	Terminated	20 Apr 2016
Z-1399-2016	Catalog Number: 900012 OB SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	32	Class II	Terminated	20 Apr 2016
Z-1400-2016	Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	4400	Class II	Terminated	20 Apr 2016
Z-1401-2016	Catalog Number: 900028 LAPAROSCOPY SURGICAL PACK	60	Class II	Terminated	20 Apr 2016
Z-1402-2016	Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	900	Class II	Terminated	20 Apr 2016
Z-1403-2016	Catalog Number: 900036 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	132	Class II	Terminated	20 Apr 2016
Z-1404-2016	Catalog Number: 900052 MINOR PROCEDURE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	40	Class II	Terminated	20 Apr 2016
Z-1405-2016	Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	4550	Class II	Terminated	20 Apr 2016
Z-1406-2016	Catalog Number: 900064 WOUND CLOSURE TRAY II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	600	Class II	Terminated	20 Apr 2016
Z-1407-2016	Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	140	Class II	Terminated	20 Apr 2016
Z-1408-2016	Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	30	Class II	Terminated	20 Apr 2016
Z-1409-2016	Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	16	Class II	Terminated	20 Apr 2016
Z-1410-2016	Catalog Number: 9001091 PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	80	Class II	Terminated	20 Apr 2016
Z-1411-2016	Catalog Number: 900110 TRACHEOSTOMY CARE KIT WITH TRACH TUBE HOLDER FOR ADULT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	2800	Class II	Terminated	20 Apr 2016
Z-1412-2016	Catalog Number: 9001127 FOLEY CATHETER TRAY 16 FR-5CC- 2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	2920	Class II	Terminated	20 Apr 2016
Z-1413-2016	Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	380	Class II	Terminated	20 Apr 2016
Z-1414-2016	Catalog Number: 9001154 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	2088	Class II	Terminated	20 Apr 2016
Z-1415-2016	Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	1020	Class II	Terminated	20 Apr 2016
Z-1416-2016	Catalog Number: 9001202 LAMINECTOMY PK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	42	Class II	Terminated	20 Apr 2016
Z-1417-2016	Catalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	45	Class II	Terminated	20 Apr 2016
Z-1418-2016	Catalog Number: 9001296 PREMIUM LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	258	Class II	Terminated	20 Apr 2016
Z-1419-2016	Catalog Number: 9001297 PREMIUM OBSTETRICAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	220	Class II	Terminated	20 Apr 2016
Z-1420-2016	Catalog Number: 9001298 PREMIUM ARTHROSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	85	Class II	Terminated	20 Apr 2016
Z-1421-2016	Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	81	Class II	Terminated	20 Apr 2016
Z-1422-2016	Catalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	15	Class II	Terminated	20 Apr 2016
Z-1423-2016	Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	40	Class II	Terminated	20 Apr 2016
Z-1424-2016	Catalog Number: 9001456 WOUND MANAGEMENT TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	200	Class II	Terminated	20 Apr 2016
Z-1425-2016	Catalog Number: 9001460 REYITO PLUS UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	35	Class II	Terminated	20 Apr 2016
Z-1426-2016	Catalog Number: 9001482 ENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	70	Class II	Terminated	20 Apr 2016
Z-1427-2016	Catalog Number: 9001496 D&C LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	12	Class II	Terminated	20 Apr 2016
Z-1428-2016	Catalog Number: 9001521 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	24	Class II	Terminated	20 Apr 2016
Z-1429-2016	Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	550	Class II	Terminated	20 Apr 2016
Z-1430-2016	Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	270	Class II	Terminated	20 Apr 2016
Z-1431-2016	Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	55	Class II	Terminated	20 Apr 2016
Z-1432-2016	Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	15	Class II	Terminated	20 Apr 2016
Z-1433-2016	Catalog Number: 900169 UNIVERSAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	9	Class II	Terminated	20 Apr 2016
Z-1434-2016	Catalog Number: 9001738 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	25	Class II	Terminated	20 Apr 2016
Z-1435-2016	Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	938	Class II	Terminated	20 Apr 2016
Z-1436-2016	Catalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	3700	Class II	Terminated	20 Apr 2016
Z-1437-2016	Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	540	Class II	Terminated	20 Apr 2016
Z-1438-2016	Catalog Number: 9001780 OPHTHALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	168	Class II	Terminated	20 Apr 2016
Z-1439-2016	Catalog Number: 9001933 OPHTALMIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	168	Class II	Terminated	20 Apr 2016
Z-1440-2016	Catalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	20	Class II	Terminated	20 Apr 2016
Z-1441-2016	Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	12	Class II	Terminated	20 Apr 2016
Z-1442-2016	Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	24	Class II	Terminated	20 Apr 2016
Z-1443-2016	Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	150	Class II	Terminated	20 Apr 2016
Z-1444-2016	Catalog Number: 9002193 SHOULDER ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	42	Class II	Terminated	20 Apr 2016
Z-1445-2016	Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	280	Class II	Terminated	20 Apr 2016
Z-1446-2016	Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	24	Class II	Terminated	20 Apr 2016
Z-1447-2016	Catalog Number: 9002259A LAPAROSCOPY-COLORECTAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	84	Class II	Terminated	20 Apr 2016
Z-1448-2016	Catalog Number: 9002469 BASIC SURGICAL PACK IV Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	30	Class II	Terminated	20 Apr 2016
Z-1449-2016	Catalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	90	Class II	Terminated	20 Apr 2016
Z-1450-2016	Catalog Number: 9002511 MINOR SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	344	Class II	Terminated	20 Apr 2016
Z-1451-2016	Catalog Number: 9002516 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	76	Class II	Terminated	20 Apr 2016
Z-1452-2016	Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	18	Class II	Terminated	20 Apr 2016
Z-1453-2016	Catalog Number: 9002614 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	18	Class II	Terminated	20 Apr 2016
Z-1454-2016	Catalog Number: 9002615 EXTREMITY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	136	Class II	Terminated	20 Apr 2016
Z-1455-2016	Catalog Number: 9002618 OPEN HEART SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	47	Class II	Terminated	20 Apr 2016
Z-1456-2016	Catalog Number: 9002726 HIP AND KNEE REPLACEMENT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.	24	Class II	Terminated	20 Apr 2016

Showing 60 of 100 product records; the FDA enforcement report lists all of them.

Context

91%of 2016 device events are Class II1,232 events that year

100product records in this eventfirm median: 179

4events on this register for the firm

Other enforcement events for Customed, Inc

Initiated	Product (first record)	Type	Class	Records
10 Jul 2015	ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healin	Device	Class II	170
8 Oct 2014	Surgical packs (includes trays, bags and kits) Used by medical staff to perform patient care procedures such as wound he	Device	Class I	179
20 May 2014	Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specim	Device	Class I	233

All 4 events for Customed, Inc

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Distributed only in Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 3 May 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.